The objective of this study is to understand the patient perspective on remission in RA.
ID
Source
Brief title
Condition
- Autoimmune disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Domains of patient perceived remission
Secondary outcome
-
Background summary
Rheumatoid arthritis (RA) is an autoimmune disease characterized by persistent
inflammation and subsequent destruction of bone and cartilage in affected
joints. Chronic inflammation causes pain and physical impairment, but also
fatigue and anxiousness.
Fortunately, due to the development of new drugs, a state of remission is
becoming a realistic goal of treatment.
We have been closely involved in formulating the new definition for remission
in RA as (executive) members of the committee installed by the EULAR, ACR and
OMERACT initiative. During the development process of the new definition, it
became apparent that data on patient reported outcomes outside those agreed in
the RA core set is scarce. Also knowledge on what patients perceive as
remission is absent. These are important problems, since treatment should be
targeted at patient relevant outcomes, with patients being crucial partners in
obtaining relevant information.
Study objective
The objective of this study is to understand the patient perspective on
remission in RA.
Study design
Building on our expertise, qualitative METHODS will explore the patient
perspective on remission, through focus group discussions with patients in
ACR/EULAR remission, self declared remission or in moderate/high disease
activity in The Netherlands, Austria and The United Kingdom. From these
discussions, domains of remission will be identified.
Study burden and risks
Patients are asked to come to their own hospital twice within one week time:
The first visit involves a regular laboratory visit and joint evaluation,
similar to what patients are used to when they visit their rheumatologist.
Based on the value of the laboratory tests and the joint evaluation, patients
are assigned to one out of three group discussions.
During the second visit, the group discussion will take place. In this group
discussion, in which 6 to 8 patients will participate, we would like to find
out what the patient experience is with very low disease activity.
There are no anticipated risks or discomforts associated with participating in
this study, except the visit to the laboratory, which could involve pain at the
spot where the needle enters the skin.
de boelelaan 1117
1007 MB Amsterdam
NL
de boelelaan 1117
1007 MB Amsterdam
NL
Listed location countries
Age
Inclusion criteria
patients with:
- confirmed diagnosis of RA (1987 criteria)
- above 18 years of age
for group 1: fulfilling the ACR/EULAR remission criteria
for group 2: being in self-perceived remission
for group 3: DAS28=>3.2, with 60% having ever had an experience of remission in the past
Exclusion criteria
- patients who do not sufficiently speak the local language
- patient who do not want to sign the informed consent
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL40279.048.12 |